The Blog

BPR, what a complex regulation!

Last week I was on the loop of Biocides ECHA Stakeholders’ day. I could say that around 200 persons from all over the world took part of it. Lot of information was given, but also a lot of confusion still remains within the Biocides industry. Many questions were asked, some of them were answered and some of them are still open. However, despite of all the complexity and uncertainty that BPR seems to create within the industry I have here some take-away messages that I hope will be useful for you:

– Still not listed in ECHA’s Article 95 list? Hurry Up! You have now a six months “period of grace” to be listed. During this time the authorities rather advice than enforce Article 95. Do not miss this opportunity and act NOW. The first deadline has passed (01.09.2015), but there will not be more extension periods. It is your chance to keep your business in the EU.

-A lot of companies are questioning at the moment which route to take: Union Authorisation or National Authorisation? Stefaan Vershaeve from Sopura S.A shared his experience with the Union Authorisation and here there are some of his advices for you, future applicants: Before taking any decision on which route to take: i) consider what are your company future plans, ii) what are your customers plans, iii) what are your route to market plans iv) Involve the Top management of your company in this process v) look at the financial figures of your organization and vi) choose a knowledgeable and trustable consultant to help you to navigate through the BPR

-Overwhelmed with all the information given by the different sources (ECHA/CIRCABC/Helpdesk, etc)? Well I can tell you that you are not the only one. This was a common complain expressed by the attendees during the event and unfortunately no clear answers were given to improve the sites. However, ECHA expressed its intention to improve the search tool and stop the 15 days message to simple inquiries.

– What’s new with the ” in situ” active substances? Now the precursors in addition to active substances have to be taken into account for example in Article 95 listing. This is still an unclear issue and the practice of handling these systems is under development.

– Open issues: Still there are many questions that remain open. As for example: How will the enforcement happen? What will happen to all dossiers? How the product authorisation can be simplified? Will there be any Fee considerations for the SMEs? Will there be any actions to avoid “free riders”?

As you see dear readers, BPR is a very complex path where not many clear answers are given and not all processes are in place yet. Reminds me the early years of REACH where everybody was talking about it but no one really knew how to cope with the regulation. There is a lot of information available about Biocides, but to pick the right document can take ages and understand how this information can be addressed to ensure your business, can take a lot of resources from your company, since it will thrive the future of your business.

The reality is that despite of all the uncertainty and limitations around BPR, companies need to act now and do their homework to safeguard their future business in the EU. You may consider –especially if you are a SME- if you want to take over the BPR by yourself or if you would like to out-task this complex regulation to the experts. If the second choice is the most suitable for your company, we will be very glad in supporting your organization in any of the BPR stages and share with you our experience and expertise on BPR. More information about our support can be found at: https://www.reachlaw.fi/services/market-access-services/biocides-services/